Detailed definition of a medicinal product, typically for uses other than direct patient care (e.g. regulatory use, drug catalogs).

Business identifier for this product. Could be an MPID.

Regulatory type, e.g. Investigational or Authorized.

If this medicine applies to human or veterinary uses.

A business identifier relating to a specific version of the product, this is commonly used to support revisions to an existing product.

The status within the lifecycle of this product record. A high-level status, this is not intended to duplicate details carried elsewhere such as legal status, or authorization status.

The date at which the given status became applicable.

General description of this product.

The dose form for a single part product, or combined form of a multiple part product.

The path by which the product is taken into or makes contact with the body. In some regions this is referred to as the licenced or approved route. See also AdministrableProductDefinition resource.

Description of indication(s) for this product, used when structured indications are not required. In cases where structured indications are required, they are captured using the ClinicalUseDefinition resource. An indication is a medical situation for which using the product is appropriate.

The legal status of supply of the medicinal product as classified by the regulator.

Whether the Medicinal Product is subject to additional monitoring for regulatory reasons.

Whether the Medicinal Product is subject to special measures for regulatory reasons.

If authorised for use in children.

Allows the product to be classified by various systems.

Marketing status of the medicinal product, in contrast to marketing authorization.

Package representation for the product. See also the PackagedProductDefinition resource.

The ingredients of this medicinal product - when not detailed in other resources. This is only needed if the ingredients are not specified by incoming references from the Ingredient resource, or indirectly via incoming AdministrableProductDefinition, PackagedProductDefinition or ManufacturedItemDefinition references. In cases where those levels of detail are not used, the ingredients may be specified directly here as codes.

Any component of the drug product which is not the chemical entity defined as the drug substance or an excipient in the drug product. This includes process-related impurities and contaminants, product-related impurities including degradation products.

Additional information or supporting documentation about the medicinal product.

A master file for the medicinal product (e.g. Pharmacovigilance System Master File). Drug master files (DMFs) are documents submitted to regulatory agencies to provide confidential detailed information about facilities, processes or articles used in the manufacturing, processing, packaging and storing of drug products.

A product specific contact, person (in a role), or an organization.

Allows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Information.

A product specific contact, person (in a role), or an organization.

Clinical trials or studies that this product is involved in.

A code that this product is known by, usually within some formal terminology. Products (types of medications) tend to be known by identifiers during development and within regulatory process. However when they are prescribed they tend to be identified by codes. The same product may be have multiple codes, applied to it by multiple organizations.

The product's name, including full name and possibly coded parts.

The full product name.

Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary.

Coding words or phrases of the name.

A fragment of a product name.

Identifying type for this part of the name (e.g. strength part).

Country where the name applies.

Country code for where this name applies.

Jurisdiction code for where this name applies.

Language code for this name.

Reference to another product, e.g. for linking authorised to investigational product.

Reference to another product, e.g. for linking authorised to investigational product.

The type of relationship, for instance branded to generic, product to development product (investigational), parallel import version.

A manufacturing or administrative process or step associated with (or performed on) the medicinal product.

The type of manufacturing operation e.g. manufacturing itself, re-packaging. For the authorization of this, a RegulatedAuthorization would point to the same plan or activity referenced here.

Date range of applicability.

The organization or establishment responsible for (or associated with) the particular process or step, examples include the manufacturer, importer, agent.

Specifies whether this particular business or manufacturing process is considered proprietary or confidential.

Allows the key product features to be recorded, such as "sugar free", "modified release", "parallel import".

A code expressing the type of characteristic.

A value for the characteristic.